Senior Executive, Quality Assurance
Full-time
Senior Executive
1 day ago
Requirements
Degree with at least 3 years of working experience in Quality System (preferably in Healthcare, Bio/Pharma, Health Services, biotechno..
Requirements
- Degree with at least 3 years of working experience in Quality System (preferably in Healthcare, Bio/Pharma, Health Services, biotechnology/biotherapies related industry)
- Good communication skills
- Team player with good coordination
- Meticulous, analytical and systematic
- Candidates with more experience will be considered for a Assistant Manager role
Descriptions
- Maintenance of organization’s quality management system in compliance to:
- regulatory requirements; MOH Healthcare Services Act and other regulatory relevant to the company’s services and products
- accreditation and certification standards; AABB (Association for the Advancement of Blood & Biotherapies), FACT (Foundation for the Accreditation of Cellular Therapy), GDP-MDS SS 620 (Good Distribution Practice for Medical Devices) and other standards when required for the company’s services/products
- Ensure requirements for AABB, FACT as well as MOH license guidelines are implemented and maintained
- Follow up and assist in deviations/ non-conformances (CAPA) for root cause analysis, rectification and process improvement
- Performance of Internal Audits and record checking and support External Audit to ensure compliance with regulatory and accreditation standards.
- Manage the Document Control system for the organization and ensure staff complies with the use of controlled and approved documents.
- Support supplier/ vendor qualification and audits
- Support change control activities
- Responsible for maintaining Quality Systems in the company.
- Responsible for monitoring and reviewing quality indicators and quality control reports across departments.
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